May 12, 2011 - See Notice NOT-OD-11-075 This Notice informs prospective applicants that the required plans for instruction in the Responsible Conduct of Research (RCR) will have page limits separate from the page limits for other combined components that are limited to 25 pages.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

September 29, 2010 (NOT-OD-11-008) - Updated Electronic Application Forms Required for F, K, T and D Submissions with Due Dates of January 25, 2011 and Beyond. Adobe B1 forms are required for due dates on or after January 25, 2011.

Program
Announcement (PA) Number: PAR-10-155

NOTICE: Applications submitted in
response to this Funding Opportunity Announcement (FOA) for Federal assistance
must be submitted electronically through Grants.gov (http://www.grants.gov)
using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R)
Application Guide.

APPLICATIONS MAY NOT BE
SUBMITTED IN PAPER FORMAT.

This FOA must be read in
conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter
called Grants.gov/Apply).

A registration process is
necessary before submission and applicants are highly encouraged to start the
process at least four (4) weeks prior to the grant submission date. See Section IV.

Purpose: This funding opportunity announcement (FOA) issued
by the National Cancer Institute (NCI) encourages applications for
institutional research career development (K12) programs from applicant
organizations that propose to promote the training and
career development of translational and clinical trials researchers. The
purpose of the Paul Calabresi Career Development Award in Clinical
Oncology (PCACO) K12 (NIH
Institutional Research Career Development K12 grant mechanism)
is to increase the number of clinicians (M.D.s, D.O.s, Pharm.D.s) and
basic research scientists (Ph.D.s. or equivalents) who are trained to design
and administer hypothesis-based pilot/Phase I, Phase II, and Phase III cancer
therapeutic clinical trials in team research settings. A PCACO can support
the research career development of clinicians only (single-track program)
or clinicians and Ph.D. basic research scientists (dual-track program). Clinical
and basic research scientists will collaborate and interact to expedite
the translation of basic science research discoveries into
patient-oriented therapeutic cancer research. The PCACO is not intended to
train laboratory-based scientists whose research will be primarily focused
upon the use of animal or other model systems.

Mechanism of Support:This FOA
will use the NIH Institutional Research Career Development K12 grant mechanism.
K12 programs may not be transferred from one institution to another (See
section VI.2).

Funds Available and Anticipated Number of Awards:The total amount awarded and the number of awards will
depend upon the mechanism numbers, quality, duration, and costs of the
applications received. Awards are renewable.

Budget and Project Period: Direct
costs are limited from $750,000 annually (single-track) to $1,050,000 annually
(dual-track). The project award duration for this funding opportunity may not
exceed 5 years.

Application
Institutional Career Development Plan Component Page Length: Items
2-5 (Background, Career Development Program Plan [uploaded using Program Plan],
Recruitment and Retention Plan to Enhance Diversity, and Plan for Instruction
in the Responsible Conduct of Research) are limited to a combined total of 25
pages, including tables, graphs, figures, diagrams, and charts (see Section 8 of the SF424 (R&R)
Application Guide)

Eligible Project Directors/Principal
Investigators (PDs/PIs): Individuals with the
skills, knowledge, and resources necessary to carry out the proposed
institutional research career development career development program are
invited to work with their institution/organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
support. The program leader must be an established
investigator in patient-oriented research with independent funding in
cancer-focused research. The PI must be able to provide both administrative and
scientific leadership to the Program.

Number of PDs/PIs: More than one PD/PI (i.e.,
multiple PDs/PIs), may be designated on the application.

Number
of Applications: Applicants may submit more than one
application, provided each application is scientifically distinct.

Resubmissions: Applicants may submit resubmission applications, but such applications must include an Introduction addressing
the previous peer review critique (Summary Statement). See new NIH policy on
resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals: Renewal
applications are allowed for this
institutional research career development program

This funding opportunity announcement (FOA) issued by the
National Cancer Institute (NCI) encourages applications for institutional
research career development (K12) programs from applicant organizations that
propose to promote the training and career development of
translational and clinical trials researchers. The purpose of the Paul Calabresi Career Development Award
in Clinical Oncology (PCACO) K12 (NIH Institutional Research
Career Development K12 grant mechanism) is to
increase the number of clinicians (M.D.s, D.O.s, Pharm.D.s,) and basic research
scientists (Ph.D.s, or equivalents) who are trained to design and administer
hypothesis-based pilot/Phase I, Phase II, and Phase III cancer therapeutic
clinical trials in team research settings. A PCACO can support the research
career development of clinicians only or clinicians and Ph.D. basic research
scientists. Clinical and basic research scientists will collaborate and
interact to expedite the translation of basic science research discoveries into
patient-oriented therapeutic cancer research. The PCACO is not intended to
train laboratory-based scientists whose research will be primarily focused upon
the use of animal or other model systems.

Background

The NCI embarked on a pilot program
initiative in 1991 that prepared clinical oncologists to be effective
scientific partners with basic research scientists. These well-trained clinical
oncology researchers communicated, interacted, and collaborated with basic
research, translational, and behavioral scientists in the design and
implementation of hypothesis-driven clinical trials. The initial pilot program
was highly successful and generated considerable interest in the cancer
research community. This pilot program initiative was further implemented
through two successive Requests for Applications, and in 1994, the Program was
changed from supporting only clinician scientists to one that supports both
clinician scientists and basic research scientists. Later, the program was
renamed the Paul Calabresi Award in Clinical Oncology (PCACO) in honor of the
late Dr. Paul Calabresi, who was a pioneer in the pharmacological treatment of
cancer and early translational research.

The advent of an increased emphasis on team
science has spurned the dynamic development of the Clinical and Translational
Science Awards (CTSAs), beginning in 2006, sponsored by the National Center for Research Resources. Similar to the PCACO, the CTSAs strive to drastically
increase clinical and translational research programs in institutions
nationwide and provide training and career development experience for the CTSA
scholars. Currently, the PCACO is specific to NCI for its emphasis on cancer
research.

Program Description

This funding opportunity announcement (FOA) encourages applications from applicant organizations that propose
creative and innovative institutional research career development programs in
the mission area(s) of the NCI.The NIH K12 grant mechanism (NCI PCACO) is a specialized grant
program designed to foster the development of biomedical, behavioral, and
clinical researchers through creative and innovative institutional career
development programs. The overall goal(s) of the NCI’s Research Career Development programs are to ensure that
highly trained scientists will be available in
adequate numbers and in appropriate scientific areas to address the Nation’sbiomedical,
behavioral, and clinical research needs.

The purpose of the Paul Calabresi
Career Development Award in Clinical Oncology (PCACO) K12 (NIH Institutional
Research Career Development K12 grant mechanism) is to increase the number of
clinicians (M.D.s, D.O.s) and basic research scientists (Ph.D.s, Pharm.D.s, or
equivalents) who are trained to design and administer hypothesis-based pilot/Phase
I, Phase II, and Phase III cancer therapeutic clinical trials in team research
settings. A PCACO can support the research career development of senior fellow
and/or junior faculty level clinicians only or senior fellow and/or junior
faculty level clinicians and postdoctoral Ph.D. basic research scientists. Clinical
and basic research scientists will collaborate and interact to expedite the
translation of basic science research discoveries into patient-oriented
therapeutic cancer research. The PCACO is not intended to train
laboratory-based scientists whose research will be primarily focused upon the
use of animal or other model systems.

Unique features of PCACO include:1) a requirement for
representation of at least 2 oncology specialties among the faculty and the K12
appointees (scholars); 2) mentorship by both a basic science cancer researcher
and a clinician (patient-oriented) researcher; 3) a requirement for a
laboratory-based research experience for the Scholar and the translation of the
results of this experience into clinical trials; 4) a requirement for
individualized career development programs for the K12 Scholars; 5) for dual
track K12 programs, the joint career development of clinicians with PhD basic
scientists; 6) Flexibility to accommodate K12 Scholars with different levels of
prior research training/experience; and, 7) relevant coursework.

This program announcement will
build upon the success of the last PCACO. Several significant changes are
proposed for the new FOA. First, an initial year for curriculum planning and
development, with K12 scholars beginning work in the second year of the grant
will be required for type 1 applications.The objective of this initial year is
to maximize the productivity of the curriculum planning committee and advisory
committee by allowing finalization of preparation for scholar training in the
second year of the grant. Second, limited funds (no greater than $5,000 per
year) will be allocated for external advisory committee meeting travel. These
funds will facilitate meetings of the external advisory committee. Finally,
scholar salaries will be listed as up to $100,000 in the new FOA, in accordance
with new K salary guidelines.

The NIH encourages all proposed programs to foster the
participation of individuals from racial and ethnic
groups underrepresented in biomedical and behavioral research, individuals from
disadvantaged backgrounds, individuals with disabilities, and women.

The proposed institutional research
career development program may complement other,
ongoing research training and career development programs at the applicant
institution, but the proposed career development experiences must be distinct
from those career development programs currently receiving federal support.

This FOA will
use the NIH Institutional Research Career Development (K12) award mechanism. The
PDs/PIs (if multiple PD/PI option is used) will be solely responsible for
planning, directing, and executing the proposed institutional career
development program.

This FOA uses “just-in-time” information concepts (see
SF424 (R&R) Application Guide). It also uses the non-modular budget format.
Applicants must complete and submit detailed categorical budget requests using
the SF24 Research and Related (R&R) Budget Component found in the
application package for this FOA.

Institutional career development
grant support is renewable. Institutional career development grant support is
for new and renewal (formerly “competing continuation”) applications.It is recommended that applicants contact the
scientific/research contact listed in Section VII concerning the submission of a renewal (formerly
“competing continuation”) application. Only one resubmission (formerly “revision/amendments”) of a
previously reviewed grant application may be submitted. See NOT-OD-09-003, NOT-OD-09-016.

2. Funds Available

Because the
nature and scope of the proposed institutional career development program will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of theNational Cancer Instituteprovide support for this program, awards pursuant to this
funding opportunity are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications.

The total
project period for an application submitted in response to this funding
opportunity may not exceed 5 years. Although the size
of award may vary with the scope of the institutional research career
development program proposed, it is expected that applications will stay within
the following annual budgetary guidelines: $750,000
for single-track programs and up to $1,050,000 for dual-track programs.

Facilities
and Administrative (F&A) costs requested by consortium participants, if
applicable, are not included in the direct cost limitation. See NOT-OD-05-004. .

All awards are subject to the availability of funds.

Allowable Costs

Allowable costs must be consistent with NIH
policy and be reasonable, allocable, well documented, and fully justified for
the institutional career development program proposed in the application. Grant
funds may not be used to supplant funds otherwise available at the applicant
institution. Note that instructions for completing the budget information in
the SF 424 (R&R) application, using the Research & Related (R&R)
budget, are included in Section IV, “Selecting the
Appropriate Budget Component”.

Personnel: Individuals designing, directing, and implementing the career development
program may request salary and fringe benefits appropriate for the person
months devoted to the program. Salaries requested may not exceed the levels
commensurate with the institution's policy for similar positions and may not
exceed the congressionally mandated cap. If mentoring interactions and other
activities with scholars are considered a regular part of an individual's
academic duties, then mentoring and other interactions with scholars are
non-reimbursable from grant funds. Limited program-related administrative and
clerical salary costs associated distinctly with the program that are not
normally provided by the applicant organization may be direct charges to the
grant only when specifically identified and justified. These expenses must be
itemized in Sections A and B, as appropriate, of the R&R Budget.

Program Administration Costs: If applicable and
justified, the costs of a Research Administrator and/or program assistant with
responsibilities directly associated with the institutional career development
program can be requested, and salaries must be commensurate with institutional
policy for similar positions, and specifically identified and justified. When
applicable, this expense must be itemized in Section A or B, as appropriate.

Other Program-Related Expenses: Consultant costs,
equipment, supplies, travel for key persons, and other program-related expenses
must be justified as specifically required by the proposed program and must not
duplicate items generally available for similar programs at the applicant institution. These expenses must be itemized in Sections
C, D, and F, as appropriate. Programs may
request up to $5,000 annually for External Advisory Committee travel.

Scholar Costs: Scholars are those
individuals who benefit from the proposed activities and experiences involved
in the career development program. Scholar costs must be justified as
specifically required for the proposed career development program and based on
institutional policies for salaries paid to individuals in similar positions,
regardless of the source of funds. These expenses must be itemized in Section B
(scholar salaries) and F (other program-related expenses) as appropriate.

The
NCI will provide support for each scholar position up to $100,000 salary and
associated fringe benefits per year based on a full-time professional 12
person-month effort commensurate with the applicant institution’s salary
structure for persons of equivalent qualifications, experience, and rank.

The
total salary requested must be based on a full-time, 12-month staff appointment
and requires scholar to devote a minimum of 9 person-months of full-time
professional effort to conducting career development and health-related
research with the remaining effort devoted to activities related to the development
of a successful research career. For information regarding NIH policy on
determining full-time professional effort for career awards, see: https://grants.nih.gov/grants/guide/notice-files/NOT-CA-09-022.html.

Candidates
who have U.S. Veterans’ Administration (VA) appointments may not consider part
of the VA effort toward satisfying the “full time” requirement at the applicant
institution. Candidates with VA appointments should contact the staff person in
the relevant Institute prior to preparing an application to discuss their
eligibility.

The
proposed salary must be consistent both with the established salary structure
at the institution and salaries actually provided by the institution from its
own funds to other staff members of equivalent qualifications, rank, and
responsibilities in the department concerned. If full-time, 12-month salaries
are not currently paid to comparable staff members, the salary proposed must be
appropriately related to the existing salary structure. Confirmation of
salaries may be required prior to the issuance of an award.

The
sponsoring institution may supplement the NIH salary contribution up to a level
that is consistent with the institution's salary scale. However,
supplementation may not be from federal funds unless specifically authorized by
the federal program from which such funds are derived. Additional PHS funds may
not be used for salary supplementation. Institutional supplementation of salary
must not require extra duties or responsibilities that would interfere with the
purpose of the K12 award. However, under expanded authorities, institutions may
re-budget funds within the total costs awarded to cover salaries consistent
with the institution's salary scale. The total salary, however, may not exceed
the legislatively mandated salary cap.

Mentored
career award recipients in the last 2 years of career award support may hold
concurrent support from their career award and a competing NIH research grant
when recognized as a PI or subproject director. This new policy can be found at
the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html.

Research and
Development Support: Up to $30,000 per individual scholar may be provided
for the following types of expenses: (a) research expenses, such as supplies, equipment,
and technical personnel; (b) tuition and fees related to required career
development courses and activities; (c) travel to research meetings or
training; and (d) statistical services including personnel and computer time. These
costs must be specifically documented for each individual scholar and must be both
specifically and directly related to the scholar's research activities. They
cannot be pooled and used for advertising, recruiting, or other programs
unrelated or indirectly related to the research activities of individual
scholars. It is expected that the K12 scholars will be working in a funded
research environment and that support provided by the K12 grant will augment
existing research support to include the scholar.

Items that may NOT be supported with K12
funds include: Salaries for support of ancillary personnel, i.e. mentors,
secretarial, and administrative assistance, etc.

Facilities
and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will
be reimbursed at 8 percent of modified total direct costs (excluding tuition,
fees, and equipment).

NIH Grants Policy: NIH grants
policies as described in the NIH Grants Policy Statementwill
apply to the applications submitted and awards made in response to this FOA.

Foreign institutions are not eligible to apply
in response to this FOA.

In many cases, it is anticipated that the proposed institutional
research career development program will complement other ongoing research
training and career development programs occurring at the applicant institution
and that a substantial number of program faculty will have active research
projects in which participants may gain relevant experiences consistent with
their research interests and goals.

Institutions with existing K12 or other training programs
must explain what distinguishes this program from the others, how their
programs will synergize with one another, if applicable, and make it clear that
the pool of faculty, potential scholars, and resources are robust enough to
support additional programs.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary
to carry out the proposed career development program as the PD/PI is invited to
work with his/her institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

The PD/PI should be an established,
independently funded, cancer investigator in the scientific area in which the
application is targeted who is capable of providing both administrative and
scientific leadership to the development and implementation of the proposed
institutional research career development program.

The PD/PI will be expected to monitor and assess the
program and submit all documents and reports as required. (See Section VI.3. “Reporting.”)

More than one PD/PI (i.e.,
multiple PDs/PIs), may be designated on the application for projects that
require a “team science” approach and therefore clearly do not fit the
single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at https://grants.nih.gov/grants/multi_pi.All PDs/PIs must be registered in the NIH electronic
Research Administration (eRA) Commons prior to the
submission of the application (seehttp://era.nih.gov/ElectronicReceipt/preparing.htmfor instructions).

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs grant is the responsibility of the investigators and applicant
organizations and should be determined by the scientific goals of the project.
Applications for grants with multiple PDs/PIs will require additional
information, as outlined in the instructions below. When considering the
multiple PD/PI option, please be aware that the structure and governance of the
PD/PI leadership team as well as the knowledge, skills and experience of the
individual PDs/PIs will be factored into the assessment of the overall
scientific merit of the application. Multiple PDs/PIs on a project share the
authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttps://grants.nih.gov/grants/multi_pi.

A single PD/PI application may not be
converted to a multiple PI application within a 5-year budget period. Likewise,
a multiple PD/PI application may not be converted to a single PD/PI application
within a 5-year budget period.

Sponsoring Institution: The sponsoring institution must
assure support for the proposed institutional career development program.
Appropriate institutional commitment to the program includes the provision of
adequate staff, facilities, and relevant resources that can contribute to the
planned program. Applicant institutions must also guarantee the required
protected time for the scholars selected for support. The application must
include a letter explaining the institutional commitment to the proposed
institutional research career development program (see Section IV.6, item 14).

Scholars:Appointees to the Program must be designated “Paul
Calabresi Scholars”.

Individuals
to be supported by the institutional career development program must be at the
career level for which the planned program is intended. Scholars are expected
to devote a minimum of 9 person-months (75% of full-time professional effort)
during the appointment on the K12 award. This
effort may be reduced to 6 person-months (50% of full-time professional effort)
for surgeons. Clinician Candidates (required): All
clinician candidates must currently be physicians holding the M.D. or D.O.
degrees, Pharm.D.s, or be nurses with a clinical Ph.D. degree; and must have
completed the necessary clinical training (i.e., completed residency and
are board eligible) to engage in clinical oncology research.

Basic Science Candidates
(encouraged but optional): All basic science candidates must have
doctoral-level degrees (e.g., Ph.D., or the equivalent), a minimum of 2 years
of postdoctoral research training, and a total basic science research
experience that is clearly preparatory (e.g., experience with animal models or
preclinical research) for devoting a career to human therapeutic cancer
research.

The program must involve clinical and basic science scholars
representing at least two clinical oncology disciplines such as medical
oncology, surgical oncology, radiation oncology, pediatric oncology,
gynecologic oncology, and oncology nursing. Clinical scholars from non-oncology
medical subspecialties (e.g., thoracic surgery, pulmonology) may also be
represented in the Programs. However, the research career objectives of these
scholars must clearly be the application of their medical training and
research experience to research in clinical oncology; and the individualized
career development plans developed for these scholars must be focused on
clinical oncology research.

Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Individuals who may have been or currently are a PI of an NIH R03
or R21 grant or a PHS or non-Federal award that duplicates the provisions of an
R03 or R21 grant remain eligible for an NCI K12 appointment.

Individuals are NOT eligible for an appointment if they:

have been or are currently PIs on an NCI
or NIH individual mentored career development career, e.g., K01, K07, K08,
K23 award; an NCI Transition Career Award (K22); the Pathway
to Independence (K99/R00) award; or non-PHS equivalents;

have been or are currently a PI on NIH
research grants (such as R01, Program Project (P01) or Cancer Center (P50)
grants or subprojects of such grants); and

have been or are currently a PI on
peer-reviewed non-NIH research grants over $100,000 in direct costs per
year intended for faculty independent investigators.

Due to the emphasis of the K12 on patient-focused research,
clinician scholars appointed to a K12 grant are encouraged to subsequently apply
for a K23 and not a K08 if they need additional mentored career development; a
K99/R00 if they need additional mentored career development (K99) and will then
transition to the independent stage of their research career (R00); or for a
patient-oriented NCI K22 if they need protected time to develop their
independent patient-oriented research or patient-focused translational research
program in their first independent research position.

Recipients of a K12 appointment may hold concurrent research support
(and under certain circumstances (see Allowable Costs below) salary support)
from their appointment and a competing NIH research project grant (RPG) when
recognized as a PI or subproject director of the RPG (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html)
if they have first completed at least 2 years of training supported by the K12
grant.

Applicants are strongly encouraged to consult with the scientific/research
contact person listed in Section VII of this announcement prior to the
submission of an application to discuss eligibility and program requirements.

Scholar
Citizenship and Residency Requirement: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who
have a currently valid Permanent Resident Card (USCIS Form I-551), or some
other verification of legal admission as a permanent resident prior to
admission into the K12 program, are eligible for scholar support from this
program. Non-citizen nationals, although not U.S. citizens, owe permanent
allegiance to the U.S. They are usually persons born in lands that are not
states but are under U.S. sovereignty, jurisdiction, or administration. Individuals
on temporary or student visas are not eligible.

Mentors: Mentors will interact
closely with the scholar, and should have research expertise and experience
relevant to the proposed career development program. Mentors must be committed
to continue their involvement throughout the total period of the scholar’s
career development under this award. The program must involve clinical
and basic science mentors representing at least two clinical oncology
disciplines such as medical oncology, surgical oncology, radiation oncology,
pediatric oncology, gynecologic oncology, and oncology nursing. At least 50% of
the mentors on this K12 should have independent research support in cancer.

Advisory Committee:The PI
must use an Advisory Committee (AC) to provide an oversight function and annual
evaluation of the Program as a whole. The committee's responsibilities should
include but are not limited to: selecting clinician, nurse, and basic science
scholars (Note: basic science scholars are encouraged as part of these Programs
but they are optional), assigning preceptors, approving each scholar's career
development plan, evaluating each scholar's progress, authorizing the
termination of a scholar who is not performing adequately, monitoring the
overall effectiveness of the program and recommending mid-course changes when
needed. A detailed description of the committee's composition, function,
and frequency of meetings should be provided. Plans for an annual evaluation of
the program by the AC should be described, and annual written reports from the
AC are required that describe the progress (e.g., success of scholars in
achieving core didactic and research requirements) of the Program, evaluate its
effectiveness (e.g., recruitment methods, effectiveness of mentors, effectiveness
and appropriateness of curriculum), and provide recommendations for
improvements. This annual report must also address the recruitment and
retention of individuals from underrepresented racial and ethnic groups,
individuals with disabilities, and individuals from disadvantaged backgrounds
in the Program.

Number
of Applications: Applicants may submit more than one application,
provided each application is scientifically distinct.

Resubmissions: Applicants may submit a resubmission
application, but such application must include an
Introduction addressing the previous peer review critique (Summary Statement).Beginning
with applications intended for the January 25, 2009 official submission due
date, all original new applications (i.e., never submitted) and competing
renewal applications are permitted only a single amendment (A1). See new NIH
policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
Original new and competing renewal applications that were submitted prior to
January 25, 2009 are permitted two amendments (A1 and A2). For these
“grandfathered” applications, NIH expects that any A2 will be submitted no
later than January 7, 2011, and NIH will not accept A2 applications after that
date.

Renewals: Renewal
applications are allowed for this institutional research career development (K12)
program.

Section IV. Application and
Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the steps
of the registration process could take four weeks or more. Therefore,
applicants should immediately check with their business official to determine
whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must
be complete by the submission deadline for the application to be considered
“on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

The
individual(s) designated as PDs/PIs on the application must be registered
also in the NIH eRA Commons. In the case of multiple PDs/PIs, all
PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

Each
PD/PI must hold a PD/PI account in the Commons. Applicants should not
share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however,
if they have both a PD/PI role and an Internet Assisted Review (IAR) role,
both roles should exist under one Commons account.

When
multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization
must be affiliated with that organization. PDs/PIs located at another
institution need not be affiliated with the applicant organization, but
must be affiliated with their own organization to be able to access the Commons.

This
registration/affiliation must be done by the AOR/SO or his/her designee
who is already registered in the Commons.

Both
the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration
process is not sequential. Applicants should begin the registration processes
for both Grants.gov and eRA Commons as soon as their organization has obtained
a DUNS number. Only one DUNS number is required and the same DUNS number must
be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1.
Request Application Information

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the “Credential” log-in
field of the “Research & Related Senior/Key Person Profile” component must
contain the PD/PI’s assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see “Frequently Asked Questions – Application
Guide, Electronic
Submission of Grant Applications”.

The
SF424 (R&R) application has several components. Some components are
required, others are optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

When
multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the
"Contact” PI, who will be responsible for all communication between the
PDs/PIs and the NIH, for assembling the application materials outlined below,
and for coordinating progress reports for the project. The contact PD/PI must
meet all eligibility requirements for PD/PI status in the same way as other
PDs/PIs, but has no other special roles or responsibilities within the project
team beyond those mentioned above.

Information
for the Contact PD/PI should be entered in item 14 of the SF424(R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of “PD/PI”. Please
remember that all PDs/PIs must be registered in the eRA Commons prior to
application submission. The Commons ID of each PD/PI must be included
in the “Credential” field of the Research & Related Senior/Key Person
component. Failure to include this data field will cause the application
to be rejected.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section
of the Research Training Program plan entitled “Multiple PD/PI Leadership Plan”,
must be included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators. A single Contact PD/PI must be designated for
the purpose of communicating with the NIH, although other individuals may
contact the NIH on behalf of the Contact PD/PI when necessary.

If
budget allocation is planned, the distribution of resources to specific
components of the program or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award.

Applications
Involving a Single Institution

When
all PDs/PIs are within a single institution, follow the instructions contained
in the SF424 (R&R) Application Guide.

Application
Involving Multiple Institutions

When
multiple institutions are involved, one institution must be designated as the
prime institution, and funding for the other institutions(s) must be requested
via a subcontract to be administered by the prime institution. When submitting
a detailed budget, the prime institution should submit its budget using the
Research & Related Budget component. All other institutions should have
their individual budgets attached separately to the Research & Related
Budget Sub-award Budget Attachments(s) Form. See Section 4.8 of the SF424
(R&R) Application Guide for further instruction regarding the use of the
sub-award budget form.

Evaluation
Plan

The
application must describe an evaluation plan to review and determine the
quality and effectiveness of the career development program. This should
include plans to obtain feedback from current and former scholars to help
identify weaknesses in the program and to provide suggestions for program
improvements, as well as plans for assessing scholars’ career development and
progression, including publications, and post-training positions. Evaluation
results should be included in future renewal applications and as part of the
Final Progress Report.

To submit an application in
response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically. PAPER
APPLICATIONS WILL NOT BE ACCEPTED.All attachments must be provided to NIH in PDF format, filenames must
be included with no spaces or special characters, and a .pdf extension must be
used.

3.C. Application
Processing

3.C.1. Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local
time (of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is
not submitted by the due date(s) and time, the application may be delayed in
the review process or not reviewed.

All
applications must meet the following criteria to be considered “on-time”:

All
registrations must be complete prior to the submission deadline

The
application must receive a Grants.gov tracking number and timestamp (or eRA
help desk ticket confirming a system issue preventing submission) by 5:00 p.m.
local time on the submission deadline date.

Any
system-identified errors/warnings must be corrected and the submission process
completed within the “error correction window”.

Submission to Grants.gov is not the last step –
applicants must follow their application through to the eRA Commons to check
for errors and warnings and view their assembled application!

3.C.2. Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has been
successfully submitted through Grants.gov, NIH provides applicants a two day error
correction window to correct any eRA identified errors or warnings before a
final assembled application is created in the eRA Commons. The standard error
correction window is two (2) business days, beginning the day after the
submission deadline and excluding weekends and standard federal holidays. All
errors must be corrected to successfully complete the submission process. Warnings
will not prevent the application from completing the submission process.

Please note that the following
caveats apply:

Initial
application submission must be “on-time”.

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that includes
additional changes.

Proof of “on-time” submission (e.g., Grants.gov timestamp and
tracking number) and description of all changes made within the window must be
documented in the PHS 398 Cover Letter component of the application.

3.C.3. Viewing
an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in
the eRA Commons, the
PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO)
have two weekdays (Monday – Friday, excluding Federal holidays) to view the
assembled application before it automatically moves
forward to NIH for further processing.

If
everything is acceptable, no further action is necessary. The application will automatically move forward to the
Division of Receipt and Referral in the Center for Scientific Review for
processing after two weekdays,
excluding Federal holidays.

Prior
to the submission deadline, the AOR/SO can “Reject” the assembled application
and submit a changed/corrected application within the two-day viewing window.
This option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and submit
a Changed/Corrected application. In these cases, please contact the eRA Help
Desk to ensure that the issues are addressed and corrected. Once rejected,
applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424
(R&R) application guide, including the requirement
for cover letters on late applications. The “Reject” feature should also be
used if you determine that warnings are applicable to your application and need
to be addressed now. Remember, warnings do not stop further application
processing. If an application submission results in warnings (but no errors),
it will automatically move forward after two week days if no action is taken. Some
warnings need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course
of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two week days.

Upon receipt, application will be evaluated for
completeness by the CSR Incomplete applications will not be reviewed.

There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
the application status in the Commons.

The
NIH will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. However, the NIH will accept a
resubmission application, but such application must include an Introduction
addressing the critique from the previous review.

All NIH awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy
Statement.

Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or renewal award if such costs: are
necessary to conduct the project, and would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewalaward.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project. See the NIH
Grants Policy Statement.

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see “Frequently
Asked Questions – Application Guide, Electronic
Submission of Grant Applications”.

PHS 398 Research Training Program Plan Component Sections

Page
limitations of the Research Career Development Program Plan (uploaded using the
PHS398 Research Training Program Plan) component must be followed as outlined
in the SF424 (R&R) Application Guide, Section 8, Supplemental Instructions
for the Institutional NRSA Application.

The Introduction (required for a resubmission
application) is limited to 3 pages.

The Introduction (required for a revision
application) is limited to 1 page.

Items 2-5 (Background, Program Plan, Recruitment
and Retention Plan to Enhance Diversity, and Plan for Instruction I the
Responsible Conduct of Research) of the (Research Career Development
Program Plan (uploaded using the PHS398 Research Training Program Plan)
application may not exceed 25 pages, including tables, graphs, figures,
diagrams, and charts.

While each Item 2-5 needs to be uploaded
separately as a PDF attachment, applicants are encouraged to construct the
Items 2-5 as a single document, separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits. When
validating for page limits, the eRA Commons will not count the white space
created by breaking the text into separate files for uploading.

All
application instructions outlined in the SF424 (R&R) Application Guide are to be followed,
with the following requirements for K12 applications:

An initial year for curriculum planning and development, with K12
scholars beginning work in the second year of the grant is required for initial
(type 1) applications. No scholars will be appointed during the first year of
the grant on these initial awards. The objective of this initial year is to
maximize the productivity of the curriculum planning committee and advisory
committee by allowing finalization of preparation for scholar training in the
second year of the grant.

Introduction
to Application (Item 1): (for Resubmission or Revision only): same as instructed
in 8.7.

Background
(Item 2): Provide the rationale for the proposed program, relevant background history,
and the need for the career development program proposed. Indicate how the
proposed program will foster the research careers of selected individuals.
Summarize the research career development activities of the major participating
unit(s) and department(s) represented in the proposed program. Include the
names and roles of participating faculty members planned to contribute to the
program.

Program Plan (Item 3): Include the following sections: Program
Administration, Program Faculty, Proposed Career Development Program, Program
Evaluation, Candidates/Scholars, and Institutional Environment and Commitment
to the Program.

Program
Administration (Item 3):Describe the acknowledged strengths, leadership and
administrative skills, and scientific expertise of the PD/PI. Include active
research and the planned strategy to be used to oversee and monitor the
program. For applications with multiple PDs/PI(s), address the Leadership Plan
and how the combined knowledge, skills and experience of the individual PDs/PIs
will enhance the likelihood of success of the program. When a Program
Administrator position is planned, a description of the scientific expertise,
leadership, and administrative capabilities essential to coordinate a program
for developing investigators must be included in the application.

Program
Faculty (Item 3): Describe the complementary expertise and experiences
of the proposed mentors for the scholars. Include active research and other
scholarly activities in which the mentors are engaged, as well as track records
of mentoring and training.

Proposed Career Development Program
(Item 3): Provide an overview of the proposed program: Describe the immediate and
long-term objectives of the program, including strategies and career
development activities that will be used to ensure that the objectives of the
FOA are met. Include information about planned courses, curricula, seminars,
workshops, or tutorials which will be incorporated into the career development
program and mentored research experiences and activities. Institutions with
existing K12 or other institutional career development training programs must
explain what distinguishes this proposal from the others, how the programs will
synergize, if applicable, and make it clear that the faculty, potential
scholars, and resources are robust enough to support additional programs. The
description should include planned strategies to be used to ensure that the
objectives are met. The PD/PI should also describe past research career
development activities/experiences including those of mentors, documenting the
success of former scholars in establishing independent productive scientific
careers. The program must include specific
Core Requirements that each scholar is expected to complete in order to meet
the Program's training objectives. All scholars graduating from the
program must complete all of these requirements either directly in this Program
or through a combination of past training experience and work conducted in this
Program.

These
requirements should include the following:

A
DIDACTIC CORE REQUIREMENT (e.g., formal courses in clinical trial design,
biostatistics, informed consent, Institutional Review Boards, data safety and
monitoring, lecture series, seminars, and journal clubs) based on the
experience and needs of each candidate. The requirements for this core
component should be the same for all scholars whether or not they have
clinician or basic science research backgrounds.

A
CLINICAL RESEARCH CORE REQUIREMENT that provides "hands-on"
experience (e.g., protocol development; preparation of IRB applications;
administration of clinical trials including patient accrual, analysis of
outcomes) in all aspects of Phase I, Phase II, and where possible Phase III
clinical trials. Except for the administration of treatment to patients,
this component should be the same for all scholars whether or not they have
clinical backgrounds or basic science research backgrounds. Basic science
scholars are expected to be full partners with clinicians and become equally
proficient in the design and the evaluation of results from translational,
therapeutic clinical trials.

A
BASIC SCIENCE RESEARCH CORE REQUIREMENT that provides a hands-on research
experience for CLINICIAN scholars for up to 2 years that results in
peer-reviewed first author publication(s) and that clearly serves as a tool for
ensuring that these scholars are fully prepared to communicate, coordinate and
collaborate with basic research scientists in the conduct of hypothesis-driven
cancer therapeutic research. Ideally, this experience should be linked to the
core clinical research component.

The
expectation of the NCI is that clinician and basic research science scholars will
enter the Program with different levels of experience that already satisfy many
of the Didactic, Clinical Research, and Basic Science Research Core
Requirements. Thus, individual scholars will need to complete only those
additional didactic and research experiences that help them meet all of the
core requirements of the Program and are likely to be supported by the Program
for different periods of time.

Scholars
are required to submit, but not necessarily obtain an investigator-initiated
research project grant.

All
scholars who successfully complete the program are expected to receive some
formal recognition from the parent institution (e.g., Masters in Clinical
Research degree or special certification in clinical research).

If basic
science scholars are included in the Program, special efforts must be
made to treat the clinician and basic science scholars as a COHORT with regard
to sharing, presenting, and discussing their research career development and
training experiences.

Program Evaluation (Item 3): Describe
an evaluation plan to review and determine the effectiveness of the program.
This should include plans to obtain feedback from current and former scholars
to help identify weaknesses and to provide suggestions for program
improvements, as well as plans for assessing scholars’ career development and
progression including degree completion (if applicable), publications, and
subsequent positions. Evaluation results should be included in future
competing continuation (renewal) applications and as part of the Final Progress
Report.

Candidates/Scholars (Item
3):Describe
in general terms the pool of potential candidates including information about
the types of prior clinical and research training and career level required for
the program. Do not name prospective Scholars. Describe the criteria to be used
for candidate evaluation in the selection of Scholars. Describe plans to
recruit candidates, including those from economically, socially, or culturally
disadvantaged backgrounds, individuals with disabilities or from racial or
ethnic groups that are currently underrepresented in biomedical, behavioral, or
clinical sciences and explain how these plans will be implemented. Provide
brief summaries of career development plans that the Program will employ. The
application should contain a description of how the career development plan
will be tailored to the needs of the prospective scholar candidates, taking
into account their past experiences and competences, and should distinguish the
plan from fellowship training. An initial year for curriculum planning and
development, with K12 scholars beginning work in the second year of the grant
is required for initial (type 1) applications. No scholars will be appointed
during the first year of the grant on these initial awards. The objective of
this initial year is to maximize the productivity of the curriculum planning
committee and advisory committee by allowing finalization of preparation for
scholar training in the second year of the grant. The appointment of Scholars
should be documented by a Statement of Appointment Form (Form 2271) and
submitted to the funding IC.

Institutional Environment
and Commitment to the Program (Item 3):The
sponsoring institution must have well-established research programs and highly
qualified faculty mentors and be the site for the institutional -program.
Describe the research infrastructure, facilities, etc., that are available and
accessible to this Program. This includes the existence of funded laboratories
and research space and activities that will meet and sustain the needs of the
Program. Provide information establishing the commitment of the applicant
institution, the Project Director/Principal Investigator (PD/PI), the Research
Administrator, if any, and the faculty mentors to providing developmental
experiences that lead to independence in biomedical, behavioral, and/or
clinical research relevant to the mission of the NCI. The application must
include a statement from the applicant institution describing the commitment to
the planned program. The institution must assure that essential time will be
allowed for the PDs/PIs, other faculty and mentors, and the required protected
time for scholars (9 person months, equivalent to 75%) selected for the
program.

Diversity
Recruitment and Retention Plan (Item 4): Provide a detailed diversity
recruitment and retention plan for the institutional career development
program. Renewal applications must provide additional detail experiences in
recruiting and retaining diverse individuals. Provide a detailed diversity
individuals from underrepresented groups during the previous award period.
Include, in a table, the total numbers of individuals who applied, were
interviewed, admitted, and participated in the program as well as the total
number of individuals from the three classes defined below.

Accordingly the NIH continues to encourage
institutions to diversify their student and faculty populations and thus to
increase the participation of individuals currently underrepresented in the
biomedical, clinical, behavioral, and social sciences such as:
individuals from underrepresented racial and ethnic groups, individuals with
disabilities, and individuals from socially, culturally, economically, or
educationally disadvantaged backgrounds that have inhibited their ability to
pursue a career in health-related research. Institutions are encouraged
to identify candidates who will increase diversity on a national or
institutional basis. The NIH is particularly interested in encouraging the
recruitment and retention of the following classes of candidates:

A. Individuals
from racial and ethnic groups that have been shown by the National Science
Foundation to be underrepresented in health-related sciences on a national
basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is
recognized that underrepresentation can vary from setting to setting;
individuals from racial or ethnic groups that can be convincingly demonstrated
to be underrepresented by the grantee institution should be encouraged to
participate in this program.

B. Individuals
with disabilities, who are defined as those with a physical or mental
impairment that substantially limits one or more major life activities.

C. Individuals
from disadvantaged backgrounds who are defined as:

1. Individuals
who come from a family with an annual income below established low-income
thresholds. These thresholds are based on family size; published by the U.S.
Bureau of the Census; adjusted annually for changes in the Consumer Price Index;
and adjusted by the Secretary for use in all health professions programs. The
Secretary periodically publishes these income levels at
http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income
backgrounds, the institution must be able to demonstrate that such participants
have qualified for Federal disadvantaged assistance or they have received any
of the following student loans: Health Professions Student Loans (HPSL), Loans
for Disadvantaged Student Program, or they have received scholarships from the
U.S. Department of Health and Human Services under the Scholarship for
Individuals with Exceptional Financial Need.

2. Individuals
who come from a social, cultural, or educational environment such as that found in certain
rural or inner-city environments that have demonstrably and recently directly
inhibited the individual from obtaining the knowledge, skills, and abilities
necessary to develop and participate in a research career.

Recruitment and retention plans related to a
disadvantaged background (C1 and C2) are most applicable to high school and perhaps to
undergraduate candidates, but would be more difficult to justify for
individuals beyond that level of academic achievement. Under extraordinary circumstances the
PHS may, at its discretion, consider an individual beyond the undergraduate
level to be from a disadvantaged background. Such decisions will be made
on a case-by-case basis, based on appropriate documentation.

Applications lacking a Diversity Recruitment
and Retention Plan will be considered incomplete and will not be reviewed.

Instruction in the Responsible Conduct of Research (Item
5):For detailed guidance on Instruction
in Responsible Conduct of Research, please refer to NOT-OD-10-019. Every scholar
supported by this training grant must receive instruction in the responsible
conduct of research. Describe the plan to provide scholars with such
instruction. The plan must address five components: format; subject matter;
faculty participation; duration of instruction; and frequency of instruction.
Renewal (Type 2) applications must, in addition, describe changes in formal
instruction over the past project period and plans for the future that address
any weaknesses in the current instruction plan. All training faculty who
served as course directors, speakers, lecturers, and/or discussion leaders
during the past project period must be named in the application.

Applications lacking a plan for instruction
in the responsible conduct of research will be considered incomplete and will not
be reviewed.

Progress Report (Item 6): For renewal
applications only, provide brief summaries of the overall career development
program that has been successful in preparing scholars for careers as
independent investigators. Include information on the career outcomes of all scholars
who have entered your program over the course of the award. Include measures of
success consistent with the nature and duration of the training period, and
additionalinformation
helpful in evaluating the impact of your program.

Select
Agent Research (Item 9): If
participating faculty proposed in the career development program are conducting
or plan to conduct research involving select agents in which scholars may
participate, follow the instructions in SF424, Section 5.5, and include
information in PHS398 Research Training Program Plan, Item 9, Select Agent
Research.

Multiple
PD/PI Leadership Plan (Item 10):If multiple PD/PIs are proposed,
explain in the Program Plan your rationale for how this will facilitate program
administration.

Letters
of Support (Item 14):
Provide the sponsoring institution’s letter of commitment and support (see
Section III.3.)

Appendix (Item 15):Applicants must follow the specific
instructions on Appendix materials as described in the SF424 (R&R)
Application Guide (See https://grants.nih.gov/grants/funding/424/index.htm). Do not use the Appendix
to circumvent the page limitations of the Research Career Development Plan
component. An application that does not comply with the required page
limitations may be delayed in the review process.

SF424
R&R Cover Component

Item 8.Type
of Application: Unless stated in
the applicable FOA, institutional K12 awards are usually renewable. Therefore,
the applicant should generally check “new” or “renewal”. PDs/PIs should check
the specific FOA to determine the types of applications that will be accepted.

Item 12.Proposed
Project (Start and Ending Dates): The requested period of support is usually five years for K12 programs.

Item 14. Project Director/Principal
Investigator (PD/PI) Contact Information: Provide the name of the PD/PI who will direct the institutional
program. The PD/PI is the individual who is responsible for providing the
scientific and administrative leadership in the development and implementation
of the proposed program.

Project/Performance
Site Locations Component

Indicate where the career
development program described in the Research and Career Development Plans will
be conducted. Include collaborating sites, if appropriate.

If
multiple sites are involved in the institutional career development program,
the applicant institution must be the primary site for the program. A justification must be
included for sites other than the applicant institution in the program
narrative.

Research
and Related (R&R) Other Project Information Component

Item 7. Project Summary/Abstract: (Do
not exceed 1 page): Provide an abstract of the entire application, including
the long-term goals and objectives of the program, key elements of the career
development plan, and brief descriptions of planned research projects. Include
the rationale and design of the program, the plannedduration and
projected number of scholars, including their levels (i.e., predoctoral,
postdoctoral, faculty).

Item
8. Project Narrative: Using no more than two or three sentences, describe
the relevance of this institutional career development program to public
health. In this section, use plain language that can be understood by a
general, lay audience.

Item
9. Bibliography & References Cited: This item should be used only
to cite reference supporting the need, rationale, and approach for the
institutional career development program described in the PHS 398 Research
Training Program Plan. Note that the Literature Cited section is captured in
this section (unlike the placement in the PHS 398). Do not include lists of
publications of project directors, mentors and scholars in this section, as
this information will be included in the biosketches.

Item
10. Facilities & Other Resources: Describe in an attachment the
institutional environment, including the facilities, laboratories, participating
departments, computer services, and any other resources to be used in the
development and implementation of the proposed program.

Item 12. Other Attachments:

Advisory Committee (when
applicable):A plan must be provided for the
appointment of an Advisory Committee to monitor the progress of the Scholars.
Composition, responsibilities, frequency of meetings, and other relevant
information should be included. Describe the composition of the Advisory
Committee, identifying the role and the desired expertise of members. A plan
for Advisory Committee approval and selection of Scholars should be included.
Describe how the Advisory Committee will function in providing oversight of the
development, implementation, and evaluation of recruitment strategies, the recruitment
and retention of candidates, and the evaluation of the overall effectiveness of
the career development program. Note that Advisory Committee members do not
need to be named in the application, particularly if they include individuals
from outside the institution.

Resource Sharing Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value of, and advance
research. When resources have been developed with NIH funds and the associated
research findings published or provided to NIH, it is important that they be
made readily available for research purposes to qualified individuals within
the scientific community. If the final data/resources are not amenable to sharing, this must be
explained in Resource Sharing section of the application. See https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

Data
Sharing Plan: Not
Applicable.

Sharing
Model Organisms: Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model organisms
and related resources, or state appropriate reasons why such sharing is
restricted or not possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

Genome-Wide
Association Studies (GWAS): Regardless of the amount requested, applicants seeking
funding for a genome-wide association study are expected to provide a
plan for submission of GWAS data to the NIH-designatedGWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. A genome-wide association study is defined as
any study of genetic variation across the entire genome that is designed to identify
genetic associations with observable traits (such as blood pressure or weight)
or the presence or absence of a disease or condition. For further
information see Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.

The
proposed sharing plan, after negotiation with the applicant when necessary,
will be made a condition of the award. Evaluation of annual non-competing
progress reports will include assessment of the dissemination practice by the
grantee. The adequacy of the resources sharing plan
and will be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
“Reporting.”

Senior/Key
Person Profile(s) Component

The PD/PI: The PD/PI must be registered in the eRA Commons and be assigned the PI role within the Commons. Follow the instructions in Part I.2
which provides information regarding required registration in the eRA Commons.

Key Personnel must include the PD/PI (or multiple PDs/PIs) as well as any other key persons, involved in developing, implementing, directing, monitoring,
evaluating, etc., who are integral to and have key roles in the proposed
institutional research career development program.

Multiple-Program Directors may be proposed
only if the FOA to which you are responding indicated the multiple PD/PIs will
be accepted. If multiple PD/PIs are proposed, explain in the Program Plan your
rationale for how this will facilitate program administration. If your
application involves Multiple PD/PIs, follow the directions in Section 4.5 to
designate the Contact PI and to assign the PD/PI role to other Senior/Key
Persons. Additionally, the application must include a Multi-PD/PI Leadership
Plan.

The PD/PI, applicable faculty and any other
individuals whose contributions are critical to the development, management and
execution of the Institutional Career Development Program Plan in a
substantive, measurable way (whether or not salaries are reimbursed) should be
identified as Senior/Key Persons. These would include the multiple PDs/PIs, if
applicable, and other program staff. Since these efforts are not project
related research endeavors, they should not be identified in Other Support
information.

Institutional
Research Career Development Program applications will use the non-modular
budget format (Research & Related Budget component) and
"Just-in-Time" concepts. See Sections II and Section IV for budgetary guidance. Instructions for
completing the R&R Budget Component are provided below. Information
regarding allowable costs is provided in the specific FOA. The R&R Budget
component includes three separate data entry screens (1) Sections A and B; (2)
Sections C through E; and (3) Sections F through K. Applicants must complete a
separate detailed budget for each year of support requested.

R&R Budget Component Research & Related Budget: Complete for each budget
period requested.

A. Senior/Key Person: complete for all senior/key persons associated with
the institutional career development program. The PD/PI (or multiple PDs/PIs) must be included here.

B. Other Personnel: complete for all other personnel (including clerical
and program administrative staff) associated with the institutional career
development program. Include here the salary costs proposed for the planned
scholars, identifying as the Project Role “Scholar”.

C. Equipment: self-explanatory.

D. Travel: include here any travel
funds requested for senior/key persons and other personnel (i.e. those persons
identified in Sections A. and B.) associated with the program.

E. Participant/Trainee
Support Costs: Do not complete this budget category (does not apply
to K12 programs).

F. Other Direct Costs: Include the funds requested for research development
costs allowed for the scholars in the program, using lines 8-10 (when
necessary), and itemize as appropriate and allowed for institutional career
development program.

G. Indirect
Costs: Indirect costs are reimbursed
at 8% of modified total direct costs (exclusive of tuition and fees and
expenditures for equipment) rather than on the basis of a negotiated rate
agreement.

K. Budget Justification: provide a detailed justification for each category
for which funds are requested. For Section F, itemize each category of support
costs per scholar and justify. Provide an explanation for all scholar research
and development costs in the Budget Justification.

Although
many of the sections of this application are separate PDF attachments, page
limitations referenced in the instructions and/or funding opportunity
announcement must still be followed. Agency validations will include checks for
page limits (and use of appropriate font). Some accommodation will be made for
sections that, when combined, must fit within a specified limitation.

Text
attachments should be generated using word processing software and then
converted to PDF using PDF generating software. Avoid scanning text attachments
to convert to PDF since that causes problems for the agency handling the
application. In addition, be sure to save files with descriptive file names.

When
attaching a PDF document to the actual forms, please note you are attaching an
actual document, not just pointing to the location of an externally stored
document. Therefore, if you revise the document after it has been attached, you must delete the previous attachment and then reattach the revised
document to the application form. Use the “View Attachment” button to determine
if the correct version has been attached.

Provide the current number of faculty
members in each participating unit and department, as well as the total
numbers of current predoctoral students and postdoctoral trainees in all
ongoing programs. (Suggested Table 1)

Provide for each participating
department/ unit the names of the proposed K12 faculty, their relevant
degrees, current position title, number of each type of current trainees
(predoctoral, M.D.s, other postdoctoral trainees) and total number of each
type of trainees (predoctoral, M.D.s, other postdoctoral trainees) for the
past 10 years. For competing renewal applications, additionally whether
the proposed faculty were also K12 faculty during the first 5 years of the
K12 grant. (Suggested Table 2)

List all current and pending training
support available to the participating faculty and department(s) that can
support postdoctoral training. Include funding source; complete
identifying number; title of the training program; name of the PI;
project period; number of training positions (predoctoral and
postdoctoral); and amount of the award. For each grant listed, name only
those participating faculty members who are also named in this application
and indicate their percent effort in those programs. Mark with an asterisk
faculty from the previous award period of the grant. (Suggested Table
3)

For each participating faculty member
indicate current (active) and pending research support that will provide
the context for research training experiences. Include all Federal,
non-Federal, and institutional research grant and contract support. If
none, state "None." Include the source of support, grant number
and title, dates of the entire project period, and annual direct costs. If
part of a larger project, identify the PI and provide the above data for
both the parent grant and the subproject. Provide the role of the
participating member on the source of support and their percent effort
commitment (in person-months). (Suggested Table 4)

For each faculty member participating in
this application, list all past and current students for whom the faculty
member has served, or is serving, as thesis advisor or sponsor (limit to
past 5 years). For each student listed, indicate: (1) the training level,
either predoctoral or postdoctoral; (2) the training period; (3) the
institution and degree received prior to entry into training, including
date; (4) title of the research project; and (5) for past students, their
current positions, and for current students, their source of support. If
students were trained by proposed faculty members at sites other than the
applicant organization, name these sites. For competing renewal
applications, mark with an asterisk the names of those individuals who are
currently training on this grant. (Suggested Table 5)

For New competing applications only,
list representative recent publications of some of the above students/trainees
named in Suggested Table 5. Individuals who were trained by proposed
participating faculty members at sites other than the applicant
organization may be included but should be specifically identified. (Suggested
Table 6)

For each participating department/unit
for each of the past 5 years, provide the characteristics of prospective
candidates meeting all of the eligibility requirements for K12 candidates. (Suggested Table 7 for New and Table 6 for Renewal competing
applications) Include the following information:

Number of individuals who have formally
applied for the career development/training program, by medical
specialties;

Number offered admission by medical
specialty;

Number who entered the career
development/training program by medical specialty;

Number who completed or are currently
in the career development/training program by medical specialty; and

Number who left before completion of
the career development/training program by medical specialty.

For programs selecting individuals exclusively
from candidates who are recruited on an academic department(s) or program
basis (e.g. to the department of hematology or interdepartmental program
in cancer therapeutics), provide data for each of the participating
departments/programs, including only those postdoctoral applicants who
could be considered eligible scholars for the proposed career development
program. For programs selecting trainees exclusively from candidates
who are recruited directly to the laboratories of the proposed faculty mentors,
list only those scholars who were actually in the laboratories of the
faculty mentors and could be considered for the program.

Indicate the credentials and application
outcomes of the eligible scholar pool as projected for the first year of
the career development program for each participating department/program.
For each candidate, indicate the previous institution attended, degree(s)
and year(s) awarded, and residency training/thesis research topic with
preceptor name. Also, indicate whether candidates were or were not offered
admission and which applicants entered the K12 program. (Suggested
Table 8 for New and Table 7 for renewal competing applications)

For New competing applications, provide
recruitment statistics indicating the number of individuals from
underrepresented racial and ethnic populations, individuals with
disabilities, and individuals from disadvantaged backgrounds meeting the
K12 eligibility requirements who applied to the participating
departments/units in each of the past 5 years. Give the number of
individuals from those groups offered admission and the number who
entered the participating departments/units. (Suggested Table 9)

For competing Renewal applications,
provide recruitment statistics indicating the number of individuals from
underrepresented racial and ethnic populations, individuals with
disabilities, and individuals from disadvantaged backgrounds meeting the
K12 eligibility requirements who applied to the K12 program and/or
participating departments/units in each of the past 5 years:

Give the number of eligible individuals
from the above mentioned populations applying, the number offered
admission and the number who entered the participating departments/units
and the K12 program (competing renewal applications). (Suggested Table
8)

For those who entered the program
during the past 5 years, for each year of the K12 program indicate
anonymously (identified with an anonymous number in sequence, rather than
by name, to safeguard privacy), and by participating department/unit
their current status (e.g., training, graduated or completed training)
and how they were supported. For those who have left the program or
completed training, include information about their subsequent career
development or employment. Do not include in these statistics individuals
supported by CURE supplements to the K12 program. (Suggested Table 9)

Section V. Application Review
Information

1. Criteria

Only the review criteria described below will be
considered in the review process.

2. Review and
Selection Process

The
mission of the NIH is to support science in pursuit of knowledge about the
biology and behavior of living systems and to apply that knowledge to extend
healthy life and reduce the burdens of illness and disability. As part of this
mission, applications submitted to the NIH for grants or cooperative agreements
to support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

Review Process

Applications that are
complete will be evaluated for scientific and technical merit by an appropriate
peer review group convened by NCI and in accordance with NIH peer review
procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As part of the initial merit review, all applications
will:

Undergo a selection process in which
only those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed and
assigned an overall impact/priority score;

Receive a written critique; and

Receive a second level of
review by the National Cancer Advisory Board.

The goals of NIH-supported research training,
education, and career development programs areto help ensure that a diverse
pool of highly trained scientists is available in adequate numbers and in
appropriate scientific areas to address the Nation’s biomedical, behavioral,
and clinical research needs. In their written critiques, reviewers will be
asked to comment on each of the following criteria in order to judge the
likelihood that the proposed program will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and considered
in assigning the overall score, and weighted as appropriate for each
application. Note that an application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus deserve
a high impact/priority score. These criteria are not listed in any order of
priority.

The NIH K12 grant mechanism is a specialized mechanism
designed to foster the development of biomedical, behavioral, and clinical
researchers through creative and innovative institutional career development
programs.

Overall
Impact: Reviewers will provide
an overall impact/priority score to reflect their assessment of the likelihood
for the institutional research career development program to exert a
sustained, powerful influence on the activities involved, in consideration of
the following five scored review criteria, and additional review criteria (as
applicable for the proposed program).

Scored
Review Criteria: Reviewers will
consider each of the five review criteria below in the determination of
scientific merit, and give a separate score for each. An application does not
need to be strong in all categories to be judged likely to have major
scientific impact. For example, a project that by its nature is not innovative
may be essential to advance a field.

Career Development Program Plan and Environment:

Does the proposed program clearly outline a plan to recruit
and develop well-qualified new investigators in an area relevant to the
objectives of the FOA?

Is the career development plan likely to contribute significantly
to the scientific development of the scholars?

How will implementation of the
proposed program advance the objectives of this funding opportunity
announcement to promote the training and
career development of translational and clinical trials researchers ?

Is there evidence of an adequate pool of potential scholars
who could benefit from receiving career development support?

Does
the career development plan seem appropriate to promote the professional
development of the scholars?

Are
the content and duration of any proposed didactic, training-related, and
research-related activities of the program appropriate?

Are appropriate timelines indicated for career
progression and transition to independence?

Does the institutional
environment in which the program will be conducted contribute to the
probability of success?

Does
the proposed career development program benefit from unique features of
the scientific environment, subject populations, or employ useful
collaborative arrangements?

Is
there evidence of appropriate collaboration among participating programs,
departments, and institutions?

Is
the institutional commitment to the proposed program appropriate? If
multiple sites are participating, is this adequately justified in terms of
the career development and research experiences provided?

Are
adequate plans provided for coordination and communication between
multiple sites (if appropriate)? Is
there sufficient assurance that the required effort of the PD/PI, mentors
and scholars will be devoted directly to the research training, career
development, and related activities?

When applicable, is there adequate documentation
describing the responsibilities of the advisory committee with regard to
the provision of input, guidance and oversight of the program?

Does the background information for advisory committee
members indicate the relevance to the program plan for career development?

Are
adequate research facilities and relevant resources being made available
for the planned program?

For programs submitting competing renewal applications,
what is the quality, overall impact, and effectiveness of their program in
developing new independent investigators?

For
institutions with other K12 programs, what is the effectiveness of the plan to
keep the career development activities of the proposed program distinct from
that offered by the other K12 Programs?

Program
Director(s)/Principal Investigator(s) (PD/PIs):

Do the PD/PI and Research Administrator (if
applicable), have the experience to develop, direct and administer the
proposed program?

Does the leadership team bring complementary and
integrated expertise to the program?

Is there evidence that an appropriate level of effort
will be devoted by the program leadership to ensure program objectives?

Are the research qualifications, scientific stature,
previous leadership and mentoring experience, and track records
appropriate for the proposed career development program?

Are the PD(s)/PI(s) currently engaged in research
relevant to the scientific area of the proposed program?

Mentors:

Do the mentors have expertise and experience, as well
as track records of past mentoring and training?

Are the quality and extent of the mentor’s roles in
providing guidance and scientific advice to the scholars acceptable?

Are the mentors currently engaged in relevant
research?

Candidates/Scholars:

What is the quality of plans
to identify, recruit, and select candidates, with a commitment to research
relevant to the mission of the FOA, and the potential to develop as
independent researchers?

Is there an appropriate plan
for the content, the phasing, and the proposed duration of the career
development plan for achieving scientific independence for the prospective
candidates?

How useful is the research
plan as a vehicle for ensuring research training for all Scholars as
described in the career development plan?

What is the likelihood that
the career development plan will contribute significantly to the
scientific development of the scholars?

Does the program
include a plan to recruit, identify, and select candidates with a
commitment to research relevant to the objectives of the FOA?

Does the program
description include a plan to recruit a diverse group of scholars locally
and nationally?

Does the plan for
selection of the scholars include all of the eligibility criteria stated
in the FOA?

Training
Record:

Is there evidence of a successful past training record
of the PD/PI and mentors, including the success of former scholars in
seeking independent support and establishing productive scientific
careers?

Are the evaluation plan and timeline adequate for
assessing the effectiveness (process and outcome) of the program in
achieving its goals and objectives?

For Renewal applications: Has
the program been adequately evaluated and has the level of success been
satisfactory? Do the results of the evaluation document a continued need
for support for this program? Is the approach for the next project period
responsive to the results of the program’s evaluation?

Additional Review Criteria

As applicable for the program proposed, reviewers will
consider the following
additional items in the determination of scientific merit, but will not give
separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical
research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information, see https://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards: Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmission
Applications: When
reviewing a Resubmission application (formerly called an amended application),
the committee will evaluate the application as now presented, taking into
consideration the responses to comments from the previous scientific review
group and changes made to the program.

Renewal
Applications: When
reviewing a Renewal application (formerly called a competing continuation
application), the committee will consider the progress made in the last funding
period. In addition, the committee will consider the following:

Has
the career development program successfully achieved its stated objectives
during the prior project period?

Has
the research career development program successfully recruited a diverse
pool of scholars (if applicable)? Has the PD/PI effectively shaped the
recruitment plan in response to recruitment outcomes?

Has the program been innovative in the past and does
it continue to demonstrate innovation?

Additional Review
Considerations

As applicable for the program proposed, reviewers will
address each of the following items, but will not give scores for these items
and should not consider them in providing an overall impact/priority score.

Diversity Recruitment and Retention Plan: Peer reviewers will separately evaluate
the diversity recruitment and retention plan after the overall score has been
determined. Reviewers will examine the strategies to be used in the recruitment
and retention of individuals from underrepresented racial and ethnic groups,
individuals with disabilities, and individuals from socially, culturally,
economically, or educationally disadvantaged backgrounds.

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in
responsible conduct of research as well as the past record of instruction in
responsible conduct of research, where applicable. Reviewers will specifically
address five Instructional Components, Format, Subject Matter, Faculty
Participation, Duration and Frequency, taking into account the characteristics
of institutional programs, detailed in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans
will not be funded until the applicant provides an acceptable, revised plan.

Select
Agents Research: Reviewers will assess the information provided in this section of the
application, including 1) the Select Agent(s) to be used in the proposed
research, 2) the registration status of all entities where Select Agent(s) will
be used, 3) the procedures that will be used to monitor possession use and
transfer of Select Agent(s), and 4) plans for appropriate biosafety,
biocontainment, and security of the Select Agent(s).

Resource
Sharing Plans:

When relevant, reviewers will comment on whether the
following Resource Sharing Plans, or the rationale for not sharing the
following types of resources, are reasonable:

Budget and Period of Support: Reviewers will consider whether
the budget and the requested period of support are fully justified and
reasonable in relation to the proposed institutional career development program
and the number of proposed scholars.

Selection Process

Applications submitted in
response to this funding opportunity will compete for available funds with all
other recommended applications. The following will be considered in making
funding decisions:

Scientific merit of the proposed project
as determined by scientific peer review.

Availability of funds.

Relevance of the proposed
Institutional Career Development Program to program priorities.

3. Anticipated Announcement and
Award Dates

Not Applicable

Section VI. Award Administration
Information

1. Award Notices

After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
Notice of Award (NoA) are at the recipient's risk. These costs may be
reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding
Restrictions.”

A formal notification in the
form of a Notice of Award (NoA) will be provided to the applicant organization.
The NoA signed by the grants management officer is the authorizing document.
Once all administrative and programmatic issues have been resolved, the NoA
will be generated via email notification from the National Cancer Institute to the grantee business
official.

Termination of
Award: When a grantee institution plans to terminate an award,
program and grants management staff at the NIH funding component must be
notified in writing as soon as possible.

Change of
Institution: The institutional career development program may not be
transferred from one institution to another.

Change of
Program: Awards are made for a specific program under the guidance
and leadership of a particular PD/PI. A change in any of these parameters
requires prior approval by the responsible program officer in the NIH funding
component. A rationale must be provided for any proposed changes in the aims of
the original, peer-reviewed program. If the new program does not satisfy this
requirement, the award will be terminated.

Change of
PD/PI: If change of the PD/PI is necessary, support of the award is
not automatic but may be continued with prior written approval by the NIH
funding component, provided that the following conditions are met. The current
PD/PI or the grantee institution must submit a written request for the change,
signed by the appropriate institutional business official, to the responsible
program officer of the NIH funding component that describes the reasons for the
change. The Biographical Sketch of the proposed PD/PI, including a complete
listing of active research grant support, must be provided. The information in
the request must establish that the goals of the original peer-reviewed
institutional career development program will remain unchanged under the
direction of the new PD/PI and that the new PD/PI has the appropriate research
and administrative expertise to lead the program. This request must be
submitted sufficiently in advance of the requested effective date to allow the
necessary time for review.

Changes in Research or Career
Development Program: Awards are made to a specific institution for
a specific program under the guidance of a particular PD/PI or PDs/PIs. Changes
in any of these parameters require prior approval by the NCI. A scientific
rationale must be provided for any proposed changes in the aims of the original
peer reviewed program. The new program will be evaluated by NCI staff to ensure
that the program remains within the scope of the original peer reviewed
research program. If the new program does not satisfy this requirement, support
could be withheld or the award could be suspended or terminated.

The following related
administrative policies apply generally to NIH Research Career Award (“K”)
programs:

A. Other Income

Awardees may retain royalties and
fees for activities such as scholarly writing, service on advisory groups,
honoraria from other institutions for lectures or seminars, fees resulting from
clinical practice, professional consultation or other comparable activities,
provided these activities remain incidental, are not required by the research
and research-related activities of this award, and provided that the retention
of such pay is consistent with the policies and practices of the grantee
institution.

All other income and fees, not
included in the preceding paragraph as retainable, may not be retained by the
career award recipient. Such fees must be assigned to the grantee institution
for disposition by any of the following methods:

The funds may be
expended by the grantee institution in accordance with the NIH policy on
supplementation of career award salaries and to provide fringe benefits in
proportion to such supplementation. Such salary supplementation and fringe
benefit payments must be within the established policies of the grantee
institution.

The funds may be
used for health-related research purposes.

The funds may be
paid to miscellaneous receipts of the U.S. Treasury. Checks should be made
payable to the Department of Health and Human Services, NIH and forwarded
to the Director, Office of Financial Management, NIH, Bethesda, MD 20892. Checks must identify the relevant award account and reason for the payment.

Usually, funds budgeted in an NIH
supported research or research training grant for the salaries or fringe
benefits of individuals, but freed as a result of a career award, may not be
rebudgeted. The awarding component will give consideration to approval for the
use of released funds only under unusual circumstances. Any proposed retention
of funds released as a result of a career award must receive prior written
approval of the NCI.

B. Leave Policies

Leave of a K12 scholar to another
institution, including a foreign laboratory, may be permitted if the proposed
experience is directly related to the purpose of the award. Only local
institutional approval is required if such leave does not exceed 3 months. For
longer periods, prior written approval of the NIH funding institute or center
NCI is required. Details on the process for submission of prior approval
requests can be found in the NIHGPS (rev. 12/03), Requests for Prior Approval,
at https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130).

To obtain prior approval, the
award recipient must submit a letter to NCI describing the plan, countersigned
by his/her mentor and the appropriate institutional official. A copy of a
letter or other evidence from the institution where the leave is to be taken
must be submitted to assure that satisfactory arrangements have been made. Support
from the career award will continue during such leave.

Leave without award support may
not exceed 12 months. Such leave requires the prior written approval of the NIH
component institute and will be granted only in unusual situations.

Support from other sources is
permissible during the period of leave without award support. Such leave does
not reduce the total number of months of program support for which an
individual is eligible.

C. Percent Effort Policies: Under certain circumstances, an
awardee may submit a written request to the awarding component requesting a
reduction in professional effort below 75 percent (equivalent to 9 person
months). Such requests will be considered on a case-by-case basis during
the award period. In no case will it be permissible to work at less than
50 percent effort (equivalent to 6 person months). The nature of the
circumstances requiring a change in the appointment status or percent effort
might include personal or family situations such as parental leave, child care,
elder care, medical conditions, or a disability. Permission to reduce the
level of effort will not be approved to accommodate job opportunities, clinical
practice, or clinical training. In each situation, the grantee
institution must submit documentation supporting the need for reduced effort
along with assurance of a continuing commitment to the scientific development
of the awardee. In addition, the awardee must submit assurance of his/her
intention to return to at least 75 percent effort as soon as possible.
During the period of reduced effort, the salary and other costs supported by
the award will be reduced accordingly. See: NOT-OD-09-036.

3. Reporting

K12
awards are NOT subject to the streamlined non-competing application process
(SNAP).Complete applications with
detailed budgets and progress reports are required annually.

The Progress
Report should provide information on the development and implementation of the
proposed career development program (including training and education in the
responsible conduct of research), any modifications to the career development
program as originally proposed, details about the applicant pool and the
participating scholars including their career level(s), gender, and
racial/ethnic backgrounds (if applicable), updates on the evaluation of the
program (if applicable), and a list of any publications and/or other materials
arising from the program.

This report should provide
information about changes in the Program, a summary of any ongoing evaluation
results , a summary report from the Program Advisory Committee (including
information about newly selected candidates, if applicable), and a description
of the research and career progress of each candidate. An overview of each
scholar's research accomplishments and goals for the coming year should be
clearly stated. These Annual Progress Reports will be closely monitored by NIH
staff to ensure that the grant is achieving the goals of the program and to
confirm that the institution is continuing to meet its goal of recruiting
promising investigators, and facilitating their career development

Examples:

A brief introductory description of the program objective.

Biographical sketches of new or replacement mentors

Biographical sketches of new scholars

Advisory Committee roles and activities during the past budget period

Progress statements for each Scholar describing the ongoing research
and didactic training experiences, as well as specific plans for the upcoming
year. Include any information about the scholars’ efforts to obtain independent
support

Mentors reports describing performance and progress of each Scholar

Description of course work, seminars, and other activities associated
with the program

Description of actions associated with the training in the responsible
conduct of research

Special Reporting Requirements

Please adapt the application for
continuation to contain the following information:

Appropriate face
page (Form Page 1) as instructed in the Form PHS 2590.

A budget page
(Form Page 2) that provides the salary and fringe benefits for each
scholar by name or by position if no individual is filling the position at
the time of the application. Provide all other budgetary information
(e.g., supplies, travel, technical help) by scholar name or by the
position broken out specifically for each scholar up to the $30,000 limit.

A brief
description of the Objectives and Goals of the Program.

A brief summary
listing by name delineating which faculty, mentors, and Advisory Committee
members have left the Program and which new individuals have been added or
are taking their places. Include for each person his or her degree and
department affiliation (or equivalent).

Biographical
sketches of:

New Faculty;

New Mentors;

New Advisory
Committee (AC) Members; and

New Scholars

The biosketches
for new faculty/mentors/AC members should include a listing of all active
research grant support for which they are the PI or co-investigator. The
biosketches for each scholar should include any Board Eligibilities or
Certifications.

Progress of
Individual Scholars: For each scholar, provide the start and end
dates (if the appointment ended during the reporting period) as mm/yyyy of
the appointment to the Program and the cumulative number of years
supported by the K12 grant; the names of the basic science and clinical
research mentors; and a brief paragraph for each scholar describing
progress toward satisfying the Didactic, Clinical Research, and Basic
Science Research Core Requirements of the Program and the projected
timetable for completing the remaining Core Requirements. The individual
reports should also include: 1) A list of publications for the scholar
resulting from their work in the Program; and 2) Descriptive titles of
clinical trials developed and/or implemented by each scholar and resulting
from their work in the program, identifying the role of the scholar in
each of the trials.

A separately
attached report from the AC summarizing the actions of the AC during the
last year, evaluating the performance of individual scholars and the
Program as a whole in meeting its objectives and the intent of the NCI,
evaluating the effectiveness of recruitment strategies and providing recommendations
for improving the Program (e.g., new mentors, changes in Core
Requirements, changes in recruitment strategies etc.) should be included. A
special section should be devoted to evaluating the “required” plan for
recruiting and retaining underrepresented individuals from
underrepresented population groups with recommendations for changing the
plan to improve its effectiveness.

A final progress report,
invention statement, and Financial Status Report are required upon either
completion of an award or relinquishment of an award.

3.A. Additional Reporting
Requirements

Financial Status Report (FSR): An annual FSR is
required and must be submitted within 90 days of the end of each budget
period. Continuation support will not be provided until the required form is
submitted and accepted.

Evaluation: In carrying out
its stewardship of human resource-related programs, the NIH may request
information essential to an assessment of the effectiveness of this program. Accordingly,
award recipients are hereby notified that they may be contacted after
completion of this award for periodic updates on various aspects of program
development, implementation, and other information helpful in evaluating the
impact of this program.

Publication and
Sharing of Research Results: Investigators are encouraged to
submit reports of their findings for publication to the journals of their
choice. For each publication that results from this award, NIH support should
be acknowledged by a footnote in language similar to the following: “This
project was supported by NIH grant number ________. Its contents are solely the
responsibility of the authors and do not necessarily represent the official
views of the NIH.”

Failure by the grantee
institution to submit the required forms in a timely, complete, and accurate
manner may result in an expenditure disallowance or a delay in any continuation
funding for the award. Forms may be found on the NIH Website at https://grants.nih.gov/grants/forms.htm.

Final Reports: A final Progress
Report and Financial Status Report are required when an award is terminated. Evaluation
results should be included as part of the Final Progress Report.

Section VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (“NIH Policy for
Data and Safety Monitoring,” NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (https://grants.nih.gov/grants/policy/data_sharing).Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local institutional review board (IRB) rules, as well as local,
State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see https://grants.nih.gov/grants/gwas/.

Sharing of Model
Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data
through the Freedom of Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope of
this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should include
a description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should think about how to structure informed consent statements and
other human subjects procedures given the potential for wider use of data
collected under this award.

Inclusion of Women And
Minorities in Clinical Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as
Participants in Clinical Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the
Protection of Human Subject Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy
Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs
in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy
People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.